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PV Service Overview Process
PV

Client-sync PV service

SProviding best PV services based on our distinctive PV expertise

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Overview

End to End PV Service
Providing high-efficiency PV services using advanced AI/DX solutions
ICSR
Processing
Literature
Monitoring
PV Report
writing
  • DSUR
  • Renewal
  • PSUR/PBRER
  • RMP
iVigilance Square
Clinical PV
  • Clinical Safety Management including SMP, DSMB
  • SAE/SUSAR management
  • PMS Safety Management
Providing services that meet regulations through the client's safety management know-how during the drug development stage
Signal/Risk
  • Signal Detection
  • Risk monitoring
  • RMP/RMP Implementation
Full process support for RMP planning and implementation
Medical
Monitoring
  • Medical monitoring plan & development
  • Medical coverage Training by MA
Evidence-based medical evaluation by medical experts
PV experts assist with Oracle Argus setup
DB Set-up
  • Web reporting
  • Safety DB System Set-up (include License)
  • Training
Oracle-Argus
Dedicated
PV Experts

Reducing the HR difficulty of hiring PV experts and saving the costs of CRO firms.

Consulting

Process

Business Handshake
1
Pharmacovigilance experts with professional experience will specify the client's needs.
2
Customized service projects for clients, with transparent costs and contracts. (If necessary, proceeded with quality consulting)
3
Project team is assigned and PV service begins.

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